NCT07513389招募中2 期
Omission of Immediate Postoperative Radiation in Patients With Intermediate Pathological Risk Features and Negative Two-Week Post-Operative ctHPVDNA (OPERATION Trial)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Local-Regional Control
研究概览
简要总结
This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adjuvant radiation if they demonstrate low or intermediate pathological risk features and have negative circulating tumor HPV DNA (ctHPVDNA) two weeks post-operatively. Patients are followed with standard clinical surveillance combined with serial ctHPVDNA testing (NavDx®) to facilitate early detection of recurrence and prompt salvage therapy as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, ≥ 18 years of age (no upper age limit).
- •Biopsy proven squamous cell carcinoma.
- •p16 positive (diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+ staining intensity).
- •NavDx positive, HPV16 TTMV only.
- •AJCC 8th edition cT0-2 N1 M
- •Well lateralized tonsil (>1 cm from midline, tonsil, base of tongue, glossotonsillar sulcus primary tumors.
- •≤ 2 lymph nodes, each ≤ 3cm, -OR- 1 lymph node >3 but < 6 cm.
- •≤10 pack-years of cigarette smoking or no cigarette smoking for ≥ 5 years (regardless of pack years).
- •Anatomically (e.g. adequate exposure) and physically amenable to TORS per the judgement of the operating surgeon.
- •Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to surgery; at a minimum CT imaging of the chest. PET/CT is acceptable.
- •ECOG Performance Status 0-
- •CBC with differential obtained within 8 weeks prior to surgery, with adequate bone marrow function defined as follows:
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin ≥ 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable. Transfusion must be completed within 2 to 4 weeks prior to enrollment.)
- •Adequate renal and hepatic function within 8 weeks prior to surgery, defined as follows:
- •Serum creatinine < 2.0 mg/dl.
- •Total bilirubin ≤ 1.5 x the institutional ULN.
- •Negative pregnancy test within 2 weeks prior to surgery for women of childbearing potential.
- •Eligible for platinum chemotherapy. Chemotherapy drugs allowed: cisplatin, carboplatin/paclitaxel, carboplatin/abraxane, per treating physician (cisplatin preferred, 2nd preference carboplatin/paclitaxel or carboplatin/abraxane).
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional year after surgery per MD discretion. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).
排除标准
- •Prior history of surgery to the head and neck that in the opinion of the investigators would modify prognostic significance of pathology results.
- •Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam.
- •Prior history within 5 years of cancer with the exception of:
- •Basal cell carcinoma of the skin
- •Squamous cell carcinoma of the skin, stage 1-2
- •Prostate cancer without distant metastases (stage M0)
- •Thyroid cancer without distant metastases (stage M0)
- •Prior history of squamous cell carcinoma of a mucosal site in the head or neck treated with surgery alone.
- •Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.
- •Current smoker or tobacco user.
- •Severe, active co-morbidity, defined as one or more of the following:
- •Unstable angina and/or congestive heart failure requiring inpatient hospitalization within the last 6 months.
- •Transmural myocardial infarction within the last 6 months.
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- •Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- •--- Note, however, coagulation parameters are not required for entry into this protocol.
- •Evidence of active systemic lupus or scleroderma.
- •Psoriatic arthritis.
- •Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population.
- •-- Note: HIV testing at the time of enrollment is not required.
- •Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for the immediate post-op period (1-2 weeks). Females will be determined to be not of child-bearing potential with a history of hysterectomy or with postmenopausal status of >12 months.
- •Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting one month prior to screening and for one year after surgery per MD discretion.
- •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
研究组 & 干预措施
Active Surveillance With ctHPVDNA After Surgery
Experimental
Participants with negative postoperative ctHPVDNA are observed without adjuvant radiation and followed with routine clinical surveillance and serial ctHPVDNA testing.
干预措施: Active Surveillance With ctHPVDNA (NavDx®) (Other)
结局指标
主要结局
Local-Regional Control
时间窗: 2 years post-surgery
Proportion of participants without local or regional recurrence above the clavicles at 2 years following definitive surgery, including participants who recur but are successfully salvaged with radiation or chemotherapy during the 2-year postoperative period.
次要结局
- Progression-Free Survival (PFS)(2 years after definitive surgery)
- Distant Metastasis-Free Survival (DMFS)(2 years after definitive surgery)
- Overall Survival (OS)(2 years after definitive surgery)
- Swallowing Function (Functional Oral Intake Scale - FOIS)(Baseline through 24 months post-surgery)
- Swallowing-Related Symptoms (Eating Assessment Tool-10 - EAT-10)(Baseline through 24 months post-surgery)
- ctHPVDNA Detection of Recurrence(Up to 5 years)
- Time From ctHPVDNA Positivity to Clinical Detection(Up to 5 years)
研究者
Bhishamjit Chera
Professor-Faculty
Medical University of South Carolina
研究点 (1)
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